(83 days)
K802586A, K961859
Not Found
No
The device description focuses on mechanical components (valves, reservoirs, occluders, connectors) and their function in shunting CSF. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used in the "treatment of hydrocephalic patients" by shunting cerebrospinal fluid, which indicates a therapeutic purpose.
No
The device is a component in systems designed to shunt cerebrospinal fluid (CSF) in hydrocephalic patients, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a physical valve made of silicone elastomer with internal components and connectors, designed for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to shunt cerebrospinal fluid (CSF) from the brain to other parts of the body for the treatment of hydrocephalus. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The description details a physical device (valve) implanted in the body to manage fluid flow.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting. This device is a surgically implanted medical device used for treatment.
N/A
Intended Use / Indications for Use
The Gemini Standard and Mini Valves are utilized in the treatment of hydrocephalic patients. They are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneal cavity.
Product codes
JXG
Device Description
The Gemini Standard and Mini Valves are contoured silicone elastomer valves substantially equivalent to legally marketed predicate devices used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valves incorporate an internal low, medium or high pressure valve assembly which is mounted distal to an integral pumping reservoir for proximal control of CSF flow. The devices also prevent retrograde flow. Integral occluders are incorporated on the proximal and distal ends of the valves. The occluders are designed to manually control the flushing or pumping of CSF proximally or distally. The devices are fitted with a polypropylene needle guard, designed to prevent needle puncture through the valve base during percutaneous injection. The devices contain an integral plastic connector on each end to simplify the attachment of the catheters during the clinical procedure. The devices do not contain any ferrous metal parts which would interfere with magnetic resonance imaging or computerized axial tomography.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral ventricles of the brain, right atrium of the heart, peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or qualified personnel under the direction of a physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K802586A, K961859
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).
0
MAR | 0 1998
/C974708
Image /page/0/Picture/2 description: The image shows a black square with a white design inside. The design consists of four curved lines that start at the bottom of the square and curve upwards and to the left. The lines are parallel to each other and evenly spaced. The overall design is simple and abstract.
NeuroCare Group™
CAMINO® HEYER-SCHULTE®
NEURO NAVIGATIONAL® REDMOND™
December 16, 1997 Date:
Lori Hays Contact:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is:
Name:
Gemini Standard and Mini Valves
Shunt. Central Nervous System and Components Classification Name:
The Gemini valves are substantially equivalent to other CSF shunting valves currently marketed known as the Heyer-Schulte NeuroCare Low-Profile Valves (LPV, Mini-LPV and ProfileVS). K802586A. and the Heyer-Schulte NeuroCare NOVUS Standard and Mini Valves, K961859, with respect to the functionality, design, placement and use in the neurosurgical arena.
The Gemini Standard and Mini Valves are contoured silicone elastomer valves substantially equivalent to legally marketed predicate devices used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valves incorporate an internal low, medium or high pressure valve assembly which is mounted distal to an integral pumping reservoir for proximal control of CSF flow. The devices also prevent retrograde flow. Integral occluders are incorporated on the proximal and distal ends of the valves. The occluders are designed to manually control the flushing or pumping of CSF proximally or distally. The devices are fitted with a polypropylene needle guard, designed to prevent needle puncture through the valve base during percutaneous injection. The devices contain an integral plastic connector on each end to simplify the attachment of the catheters during the clinical procedure. The devices do not contain any ferrous metal parts which would interfere with magnetic resonance imaging or computerized axial tomography.
1
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1, 0 1998
Ms. Lori Hays, MT (ASCP) ·Regulatory Submissions Specialist Heyer-Schulte NeuroCare, L.P. 8401 102nd Street, Suite 200 P.O. Box 390 Pleasant Prairie, Wisconsin 53158-0390
Re: K974708 Trade Name: Gemini Stantard and Mini Valves Regulatory Class: II Product Code: JXG Dated: December 16, 1997 Received: December 17, 1997
Dear Ms. Hays:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
2
Page 2 - Ms. Hays
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 8 - DEVICE INDICATIONS FOR USE
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Gemini Standard and Mini Valves
Indications for Use: The Gemini Standard and Mini Valves are utilized in the treatment of hydrocephalic patients. They are components in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneal cavity.
This device should only be used by a physician or qualified personnel under the direction of a physician.
Care must be taken to ensure compliance with the manufacturer's instructions for use.
Prescription Use Only (Per 21 CFR 801.109)
Prescription Use
(Per 21 CFR 801.109)
bcoelefo
(Division Sign-Off)
Division of General Restorative Devices 1974700
510(k) Number